FDA approves Yutiq for chronic non-infectious uveitis

Yutiq, a non-bio-erodible intravitreal micro-insert containing 0.18 mg fluocinolone acetonide, received FDA approval for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye.

Khanna Institute Of Lasik
Khanna Institute Of Lasik

The FDA received clinical data from two randomized, sham injection-controlled, double-masked phase 3 clinical trials of Yutiq with patient follow-up of 3 years. Both trials achieved the primary efficacy endpoint of prevention of recurrent uveitis flares after 6 months and 12 months, according to the release.

The first trial met its primary efficacy endpoint at 6 months with statistical significance (P < .01), as 18.4% of patients treated with Yutiq experienced uveitis recurrence compared with 78.6% of control patients. In the second trial, 21.8% of patients treated with Yutiq experienced uveitis recurrence at 6 months compared with 53.8% of control patients (P < .01), the release said. The efficacy in both studies was carried out to 12 months.

The 24- and 36-month follow-up data from the first phase 3 trial are expected to be released by the end of this year and the first half of 2019, respectively, according to the company.

Uveitis

Overview

Uveitis is a form of eye inflammation. It affects the middle layer of tissue in the eye wall (uvea).

Uveitis (u-vee-I-tis) warning signs often come on suddenly and get worse quickly. They include eye redness, pain and blurred vision. The condition can affect one or both eyes. It primarily affects people ages 20 to 50, but it may also affect children.

Possible causes of uveitis are infection, injury, or an autoimmune or inflammatory disease. Many times, a cause can’t be identified.

Uveitis can be serious, leading to permanent vision loss. Early diagnosis and treatment are important to prevent the complications of uveitis.

Uvea where uveitis occurs

Symptoms

Eye with uvea

The signs, symptoms and characteristics of uveitis include:

  • Eye redness
  • Eye pain
  • Light sensitivity
  • Blurred vision
  • Dark, floating spots in your field of vision (floaters)
  • Decreased vision

Symptoms may occur suddenly and get worse quickly, though in some cases, they develop gradually. They may affect one or both eyes.

The uvea is the middle layer of tissue in the wall of the eye. It consists of the iris, the ciliary body and the choroid. The choroid is sandwiched between the retina and the sclera. The retina is located at the inside wall of the eye and the sclera is the outer white part of the eye wall. The uvea provides blood flow to the deep layers of the retina. The type of uveitis you have depends on which part or parts of the eye are inflamed:

  • Iritis (anterior uveitis) affects the front of your eye and is the most common type.
  • Cyclitis (intermediate uveitis) affects the ciliary body.
  • Choroiditis and retinitis (posterior uveitis) affect the back of your eye.
  • Diffuse uveitis (panuveitis) occurs when all layers of the uvea are inflamed.

In any of these conditions, the jelly-like material in the center of your eye (vitreous) can become inflamed and infiltrated with inflammatory cells.

When to seek medical advice

Contact your doctor if you think you have the warning signs of uveitis. He or she may refer you to an eye specialist (ophthalmologist). If you’re having significant eye pain and unexpected vision problems, seek immediate medical attention.

Causes

In about half of all cases, the specific cause of uveitis isn’t clear. If a cause can be determined, it may be one of the following:

  • Eye injury or surgery
  • An autoimmune disorder, such as sarcoidosis or ankylosing spondylitis
  • An inflammatory disorder, such as Crohn’s disease or ulcerative colitis
  • An infection, such as cat-scratch disease, herpes zoster, syphilis, toxoplasmosis, tuberculosis, Lyme disease or West Nile virus
  • A cancer that affects the eye, such as lymphoma

Risk factors

People with changes in certain genes may be more likely to develop uveitis. In addition, a recent study shows a significant association between uveitis and cigarette smoking.

Complications

Left untreated, uveitis can cause complications, including:

A New Option

EyePoint Pharmaceuticals’ Yutiq injectable implant should last about the same amount of time as the Retisert implant, and it uses the same corticosteroid found in Retisert at approximately one-third of the dose (0.18 mg vs 0.59 mg), Dr. Suhler says.1

Yutiq, which was FDA approved in October 2018, is supplied in a sterile single-dose preloaded applicator that is administered through an in-office procedure called pars plana intravitreal injection, says Dario Paggiarino, MD, chief medical officer of EyePoint Pharmaceuticals, Inc.

Yutiq is a non-bio-erodible intravitreal micro-insert that employs EyePoint Pharmaceuticals’ Durasert drug delivery technology. It allows for sustained-release delivery of small molecules for up to 3 years with a single local injection. The technology is already being used in 4 other FDA-approved products.

A Better Alternative

The delivery of steroids locally in the eye eliminates the problem of systemic side effects from oral steroids. “The list of adverse side effects from oral steroids is quite lengthy,” says David Callanan, MD, partner at Texas Retina Associates in Dallas, Texas, who conducted clinical trials for Yutiq. Suppressing the immune system systemically can increase the risk of infection. Immunosuppressants also can cause adverse effects like fatigue or gastrointestinal issues.

Contraindications

  • Ocular or periocular infections 
  • Hypersensitivity 

Warnings and Precautions

  • Intravitreal injections have been associated with endophthalmitis, eye inflammation, increased intraocular pressure, and retinal detachments. Patients should be monitored following the injection. 
  • Use of corticosteroids may produce posterior subcapsular cataracts, increased intraocular pressure, glaucoma, and may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses. 
  • The implant may migrate into the anterior chamber if the posterior lens capsule is not intact. 

Adverse Reactions

  • In controlled studies, the most common adverse reactions reported were cataract development and increases in intraocular pressure. 

Generated

FDA approves Yutiq for persistent non-infectious uveitis


Yutiq, a non-bio-erodible intravitreal micro-insert consisting of 0.18 mg fluocinolone acetonide, obtained FDA authorization for the treatment of persistent non-infectious uveitis impacting the posterior section of the eye.

The FDA got clinical information from 2 randomized, sham injection-controlled, double-masked stage 3 clinical trials of Yutiq with patient follow-up of 3 years. Both trials accomplished the main effectiveness endpoint of prevention of recurrent uveitis flares after 6 months as well as one year, according to the release.

The first test fulfilled its main efficiency endpoint at 6 months with analytical significance (P <.01), as 18.4% of clients treated with Yutiq experienced uveitis recurrence compared to 78.6% of control patients. In the second test, 21.8% of patients treated with Yutiq experienced uveitis reappearance at 6 months compared with 53.8% of control patients (P <.01). The efficiency in both studies was accomplished to 12 months.
The 24- and 36-month follow-up information from the initial stage 3 trial are anticipated to be released by the end of this year as well as the very first half of 2019, specifically, according to the firm.

Uveitis

Summary
Uveitis is a form of eye inflammation. It affects the central layer of tissue in the eye wall (uvea).
Uveitis (u-vee-I-tis) warning signs typically begin suddenly and worsen swiftly. They include eye inflammation, pain and also obscured vision. The condition can affect one or both eyes. It mainly affects individuals ages 20 to 50, but it may also affect kids or younger people.

Possible sources of uveitis are infection, injury, or an autoimmune or inflammatory illness. Often times, a reason cannot be recognized.

Uveitis can be severe and may, bring about long-term vision loss. Early diagnosis as well as treatment are necessary to stop the problems of uveitis from progressing.

Signs and symptoms
Eye with uvea
The indications, signs and qualities of uveitis consist of:
– Eye redness
– Eye discomfort
– Light sensitivity
– Obscured vision
– Dark, drifting areas in your line of vision (floaters).
Reduced vision.

Lazy eye transformation by PI

Signs may occur all of a sudden as well as get worse promptly, though in many cases, they develop gradually. They may affect one or both eyes.

The uvea is the middle layer of tissue in the wall surface of the eye. It consists of the iris, the ciliary body and the choroid. The choroid is sandwiched in between the retina and the sclera. The retina is located at the inside wall surface of the eye and also the sclera is the external white part of the eye wall. The uvea offers blood circulation to the deep layers of the retina. The sort of uveitis you have depends upon which part or parts of the middle layer tissue of the eye are inflamed as follows:


– Iritis (anterior uveitis) affects the front of your eye as well as is one of the most common type.
– Cyclitis (intermediate uveitis) impacts the ciliary body.
– Choroiditis and also retinitis (posterior uveitis) influence the rear of your eye.
– Scattered uveitis (panuveitis) happens when all layers of the uvea are inflamed.

In any one of these conditions, the jelly-like substance in the center of your eye (gel-like) can end up being inflamed as well as infiltrated with inflammatory cells.
When to seek medical advice
Get in touch with your medical professional if you assume you have the warning signs of uveitis. She or he might refer you to an ophthalmologist (eye doctor). If you’re having considerable eye pain and unanticipated vision troubles, look for instant clinical attention.

Causes
In around half of all cases, the specific source of uveitis isn’t clear. If a cause can be established, it might be among the following:.
– Eye injury or surgical procedure
– An autoimmune disorder, such as sarcoidosis or ankylosing spondylitis
– An inflammatory disorder, such as Crohn’s disease or ulcerative colitis
– An infection, such as cat-scratch disease, herpes zoster, syphilis, toxoplasmosis, tuberculosis, Lyme illness or West Nile virus
– A cancer that impacts the eye, such as lymphoma

Risk Factors
Individuals with changes in specific genes might be more probable to get uveitis. Furthermore, a recent study shows a considerable association in between uveitis and also smoking.
Complications

Left neglected, uveitis can create complications, including:.
– Glaucoma
– Cataracts
– Optic nerve damage
– Retinal detachment
– Permanent vision loss

A New Alternative.
EyePoint Pharmaceuticals’ Yutiq injectable dental implant should last about the same amount of time as the Retisert implant, as well as it utilizes the exact same corticosteroid present in Retisert at roughly one-third of the dosage (0.18 mg vs 0.59 mg).
Yutiq, which was FDA approved in October 2018, is provided in a sterilized single-dose preloaded applicator that is carried out through an in-office procedure called the pars plana intravitreal injection.
Yutiq is a non-bio-erodible intravitreal micro-insert that employs EyePoint Pharmaceuticals’ Durasert medicine delivery technology. It permits sustained-release delivery of small molecules for up to 3 years with a solitary local injection. This modern technology is already being used in 4 other FDA-approved medications.

A Better Option
The delivery of steroids locally in the eye eliminates the problem of systemic negative effects from oral steroids. “The list of negative side effects from oral steroids is fairly lengthy. Subduing the immune system systemically can boost the threat of infection. Immunosuppressants likewise can trigger damaging effects like exhaustion or intestinal issues.
Contraindications
– Eye or periocular infections.
– Hypersensitivity

Warnings and Precaution
– Intravitreal injections have actually been associated with endophthalmitis, eye inflammation, raised intraocular pressure, and retinal detachments. Patients should be monitored by their ophthalmologist while taking the injections.
– Use of corticosteroids may generate posterior subcapsular cataracts, raised intraocular pressure, glaucoma, as well as might enhance the establishment of secondary eye infections because of microorganisms, fungi, or viruses.
– The ocular implant may move into the anterior chamber if the posterior lens capsule is not intact.


Adverse Reactions

– In controlled studies, one of the most typical adverse reactions reported were cataract growth and also increases in intraocular pressure.

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